Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.
Unità Operativa di Medicina Interna, Ospedale Maggiore, AUSL Bologna, Bologna, Italy.
Liver Int. 2017 Jan;37(1):54-61. doi: 10.1111/liv.13192. Epub 2016 Jul 19.
BACKGROUND & AIMS: The treatment of chronic hepatitis B infection (CHB) in children is still an area of great uncertainty. Vitamin E is an immunostimulating/antioxidant compound proven to be safe and effective for the treatment of adult CHB. The aim of this phase 2 controlled study was to evaluate the safety and efficacy of vitamin E for the treatment of paediatric HBeAg-positive CHB.
Forty-six children were randomized in a 1:1 ratio to receive vitamin E at a dose of 15 mg/kg/day (in galenic preparation) or no treatment for 12 months and were monitored for the subsequent 12 months. Clinical, biochemical, haematological and serovirological evaluations were carried out every 3 months.
No significant side effects were associated with the vitamin E treatment. At the end of the study, anti-HBe seroconversion was obtained in 7 of 23 (30.4%) of vitamin E-treated versus 1 of 23 (4.3%) of the control patients (P = 0.05), while a virological response (≥2 log decrease in HBV-DNA from baseline) was observed in 9 of 23 (39.1%) vs. 2 of 23 (8.7%) respectively (P = 0.035).
Vitamin E administration for the treatment of paediatric CHB at the tested dosage has no significant side effects and may induce anti-HBe seroconversion. Vitamin E could represent a tool for the treatment of paediatric CHB.
儿童慢性乙型肝炎（CHB）的治疗仍然存在很大的不确定性。维生素 E 是一种免疫刺激/抗氧化化合物，已被证明对成人 CHB 的治疗安全有效。本 2 期对照研究旨在评估维生素 E 治疗 HBeAg 阳性小儿 CHB 的安全性和疗效。
46 例患儿按 1:1 比例随机分为维生素 E 组（剂量为 15 mg/kg/天，制成普通制剂）或对照组，各 23 例，分别接受 12 个月的治疗和 12 个月的随访。每 3 个月进行临床、生化、血液学和血清病毒学评估。
维生素 E 治疗无明显不良反应。研究结束时，维生素 E 治疗组 23 例中有 7 例（30.4%）发生抗-HBe 血清转换，而对照组 23 例中有 1 例（4.3%）发生（P = 0.05），而病毒学应答（HBV-DNA 从基线下降≥2 对数）在维生素 E 治疗组 23 例中有 9 例（39.1%），对照组 23 例中有 2 例（8.7%）（P = 0.035）。
在本研究中检测的剂量下，维生素 E 治疗小儿 CHB 无明显不良反应，可能诱导抗-HBe 血清转换。维生素 E 可能成为治疗小儿 CHB 的一种工具。
